Geister Surgical Int'l Bipolar Endoscopic Surgical Instruments
by Geister Medizin Technik GmbH
510(k) K933699
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933699 | Date27 Jan 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Geister Surgical International Bipolar Endoscopic Surgical Instruments are classified as bipolar endoscopic surgical instruments, designed for precise tissue coagulation and cutting during minimally invasive procedures. These instruments utilize bipolar energy to deliver controlled electrical current, enabling surgeons to perform delicate operations within confined spaces such as arthroscopic or laparoscopic cavities. Their endoscopic design facilitates visualization and manipulation through small incisions, reducing trauma and improving patient outcomes in general and plastic surgery applications.
These instruments are intended for single-use only, as specified in regulatory submissions. They are supplied sterile and must be handled in accordance with standard surgical protocols to maintain sterility. The devices are regulated under FDA 510(k) clearance (K933699) and fall under product code GEI, classified as FDA Class II. Storage and handling should comply with manufacturer guidelines to preserve functionality and ensure compliance with medical device regulations.
Other devices from Geister Medizin Technik GmbH
Questions
AI-generated answers, 19 Sep 2026
Are these instruments reusable or designed for single-use, and why does that matter for my procedure?
These instruments are intended for single-use only, as explicitly stated in the regulatory submission. This design choice ensures sterility and reduces the risk of cross-contamination between patients, which is critical in endoscopic surgeries where small incisions limit access for cleaning or reprocessing. Single-use also eliminates the need for sterilization validation, simplifying workflow and compliance for your facility.
How are these bipolar endoscopic instruments supplied, and what should I check before opening them?
The instruments are supplied sterile in their original packaging, ready for immediate use. Before opening, verify the sterile barrier integrity (e.g., seals, wrappers) and check the expiration date if applicable. Since they’re single-use, ensure the packaging hasn’t been compromised—any breach could compromise sterility, and the instruments must not be reused or reprocessed. Follow standard surgical protocols for handling sterile supplies to maintain a clean field.
What types of procedures are these instruments typically used for, and why is the bipolar energy feature important?
These instruments are designed for minimally invasive procedures like arthroscopy or laparoscopy, where precise tissue coagulation and cutting are needed in confined spaces. The bipolar energy delivers controlled electrical current to minimize damage to surrounding tissues, reducing bleeding and improving visibility—critical advantages in surgeries like plastic or general procedures where precision matters. The endoscopic design further enables these operations through small incisions, lowering trauma and recovery time.
How do I store these instruments to keep them functional and compliant with regulations?
Store the instruments in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Since they’re single-use, avoid storing opened or used instruments. Adhere to the manufacturer’s guidelines for shelf life and handling to ensure functionality and compliance with medical device regulations. Proper storage preserves sterility and prevents degradation of the endoscopic components.
What does the FDA clearance (K933699) under product code GEI mean for my facility’s use of these instruments?
The FDA clearance (K933699) under product code GEI confirms these instruments meet U.S. regulatory standards for bipolar endoscopic surgical devices, classified as Class II (moderate risk). This means they’ve been evaluated for safety and effectiveness through a 510(k) submission, comparing them to a legally marketed predicate device. Your facility can use them with confidence, as the clearance covers their intended use for tissue coagulation and cutting in endoscopic procedures, but always verify compatibility with your specific surgical protocols and institutional policies.